The Effect of Prophylactic FFP Administration on ECMO Circuit Longevity
Completed · Not applicable
Conditions studied: Extracorporeal Membrane Oxygenation
In brief
The purpose of this study is to assess the impact of scheduled fresh frozen plasma (FFP) administration on extracorporeal membrane oxygenation (ECMO) pump longevity in critically ill pediatric and neonatal patients. Almost all ECMO patients receive multiple FFP transfusions during their ECMO course. The investigator proposes that scheduled FFP may maintain pro and anticoagulation balance thus mitigating the need for expensive and dangerous ECMO pump changes. In addition, this may lead to less overall transfusion with all products (red blood cells, platelets, and FFP) if coagulation homeostasis is maintained. The subjects will be neonatal and pediatric patients requiring ECMO support for any reason in the pediatric and pediatric cardiac critical care units. Subjects will be randomized to receive every other day FFP infusions or FFP administration per current standard of care. ECMO pump longevity (hours) and FFP use will be compared between the two groups There is a small risk that study subjects may receive more FFP transfusions and therefore have the increased associated risks however it is also possible that these subjects may benefit from less ECMO circuit changes and/or fewer transfusions of all blood products.
Key facts
- Study ID
- NCT01903863
- Run by
- Duke University
- People needed
- 31
- Starts
- 2013-07-01
- Expected to finish
- 2016-04-01
- Last updated by the study team
- 2017-06-27
Who can join
Age: 0 and older, up to 18. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- All patients < 18 years receiving ECMO
You may not qualify if…
- Planned withdrawal of life sustaining therapy in the next 48 hours
- Previous enrollment in the study
- Patients who cannot be consented within 48 hours
- Pregnant patients
Where it is running
- Duke University Medical Center PICU and PCICU — Durham, North Carolina, United States
Full record on ClinicalTrials.gov
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